FOUR HUNDRED YEARS AGO, IN THE YEAR 1612, the King James Bible was
made available to the literate British public and those of the clergy
and crown who could read. Those of us in the pharmaceutical Industry
mark another anniversary--it is 100 years since Congress enacted the
Sherley Amendment, which prohibited the labeling of false claims. These
two events--one of which has promoted spirituality for people of many
faiths and one which has made the protection of man's health a
proper role of government--deserve to be celebrated. Return with us in
parody and style to the stern and minutely detailed regulations of the
Old Testament as if they were regulations promulgated by today's
FDA. In this way we celebrate these two remarkable events ...

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Nehemiah's Wall-The Wall of Quality

Now whosoever pursueth manufacture of salves, ointments, medicines,
as it is set forth (Isa 38:21; 2 Kings 2:21), or cosmetics (Prov.7:17,
27:9; Exod. 30:35; Ps 45:8) is required to make a master schedule, a
complaint file, put up a Tent and then build a wall around the plant
like was builder by Nehemiah when he came back from Babylon to teach the
Law. The complaint file must tell all that is known about the plant
concerning deviations in the manufacture and not only what is found
good. This is the law. It must be told the side effects to tell your
doctor even if rare and unlikely such as caused the patient who has died
to disappear. This is so--do not laugh--it is written in the Federal
Register December 8, 1950, 133:1100; October 4 1953 127: 202, 37243; and
January 30, 1955 133: 45325 and CFR 21 part 158 subsections 586 to 721,
which are things about training, calibration, adulteration, misbranding
and divers other things that may cause the warnings, recalls, seizures
or other things that peradventure can put the president in jail who
knoweth not about mice in the warehouse--this is so.

Now the Wall that is builded will keep out products of poor quality
such as might come from the Great Sea who are a warring and powerful
people who have forsaken the rules and statutes of the people from the
River which is the people West of the Great Sea who are a manufacturing
people who do not follow the Mediterranean Diet which is mostly olive
oil and tilapia and nuts but a people who eat a lot of meat--if it is
killed the right way--this is so.

The Wall and the Master Schedule will favor those who follow the
law, do what is right in the eyes of what is--much told from the
inspectors, maintain a production without blemish else a great cloud
will come upon the Tent and stir up the dust of the earth--as it was in
the beginning.

Law of Disobedience--A Rebellious Worker

Now it came to pass that in the fifth month, which was the seventh
year of the reign of Dr. Amfortas, which was the very serious European
businessman with a scientific background that was come to New Jersey to
fix a company which had a pipeline going the wrong wav that he found out
that in the company was a stubborn and rebellious worker (and others)
who did not hearken to the rules, nor the SOPs, nor what is right in the
eyes of the FDA. His superiors lay hold onto him and bring him to the
twelfth floor and say unto the Elders up there:

"This worker is rebellious and stubborn and reads not the SOP
of the aseptic fill or even anything else down there or even anything
about the small volume parenterals which are hard to make and which are
in short supply and with a terrible profit margin and the Congress is
screaming about. He keeps needles and syringes in his pocket, which is
not told in the SOP, and removes his hairnet and contaminates the place.
Our son is evil and does risky things, fears not the power of the law,
and is a danger to the work. He does these things."

"Can now our medicine and our needles and syringes suffer the
misbranding and adulteration?"

"Yes."

"What sayeth thou about his personal life, this evil man up
here before me on the twelfth floor?"

"He has most strange and offensive ways in his household, in
his garden he plants two kinds of seeds, the coriander and the olive,
last harvest the grape and the barley. God forbid. He does other evil
things such as wearing linen and wool on the same shirt such that send
at least four score and twenty particles equal to or greater than 0.5
[micro]M in diameter in the air, every second (we counted them). In the
laboratory there exists a great abomination when he makes on the same
shelf the 0.85% sodium chloride of the inorganic side with the 62.0% w/v
of the organic germicides approved by the FDA but not by the EPA, this
is so."

That he and his kind mayest fear the awful and powerful name of the
Law they took him out of the city, like in the book by Franz Kafka that
Dr. Amfortas told them. They read him a letter written by Ezra the
scribe, the son of Ephraim, who is the brother-in-law of Phineas, who is
a friend of Nehemiah who was the cupbearer to the King of Babylon during
the captivity of the consent decree, which is a warning that he has five
minutes to live. He is blindfolded and turned around 17 times. He is
then tripped and as he stumbles he says, "Why lost thou trip a
blind man?"

This is the law of the SOP. "He doesn't recant. He sleeps
with his fathers."

Of the Germs

Of the germs within the water, the environmental surfaces, mucous
membranes, skin, or divers parts of man's body that has
affliction--these you may kill.

The germs of the swellings which are the boils on the arms or
drainage in the throat that cometh from the staphylococcus or even the
streptococcus and what hath been called the "UTI" (which makes
much soreness in the man and the woman) and divers others of the
pestilence that are come amongst you, upon you--from you--with vinegar
or red wine you may kill them--they are a danger--the germs also which
have the resistance to the MRSA which is much ado about nothing because
no one uses this anymore--this is so, do not laugh--these you may
kill--also the germs of the leprosy like the TB which are from the soil
or from people in the camp who lie in very closeness together--and the
markings of the diagnosis are very real to the eyes of Aaron the
physician who is the son of Rheoboam who was married to the daughter of
Teva or Mylan, or whosoever in the camp knows the signs and symptoms of
these afflictions--do not to vinegar or red wine, for they will not
work, no, they will not work--the germs are too strong for them--but you
must look like to the molecules of the Dead Sea or elsewhere, or perhaps
to the soil for another antibiotic like that was got by Dr. Waksman for
Streptomycin when he got the Nobel Prize many years ago. That you may be
prosperous in manufacture, take note and study the nature of the
creatures of pestilence. Find them, isolate them, for it is a good thing
to kill them--a very good thing.

Of the bacterias that abideth in the milk of goat, cow or other
animal which cheweth the cud--these you may not kill. When the milk is
sour and comes with curd which is clear at the above it is from the
lactic acid bacteria which make the D-or the L-isomer of this
metabolite--these you may not kill for because they are the probiotics
which remove cramps from the stomach and bowel and are good. They are a
blessing to you--do not kill them--no, do not do that to them--and you
can make cheese from them--this is true, do not laugh--and the cheese
which may cometh from the milk and the bacteria therein will nourish
your kinsmen, the stranger, the widow and even the orphan which may come
before thy gate--as it is said, let them alive--it is a good thing.

The Law of the E. coli

If a food or medicine has the E. coli in it then it is unclean unto
you and must be destroyed, yea even unto every batch in the plant of the
manufacturing. When the plague of the E. coli is in the food of any sort
or the medicine that is taken by mouth at sundown or anytime then it
shall be brought to the lab and, behold, if the serological group O15:H7
of the hemorrhagic colitis from a pig is found or any animal that does
not chew the cud or cleaves the hoof or does not cleave the hoof but
chews the cud is found in the lab, the thing must be told to the
Director of Quality Control and then to the King. The King shall then
see if the food or medicine has been shipped into the pipeline and then
do the thing called the "recall" and tell the Government and
then the New York Times before the Government does this. The New York
Times will leak this thing to Nathan or to either Samuel I or Samuel
II--it makes no difference but not to Amos, Hosea or Isiaiah or even
Ezekiel because they have not been born and will make plenty of their
own trouble when they start complaining and predicting about other
things in the future.

When Nathan or Samuel I or II tell the FDA they will send 15 men to
knock on the gates and say "We are here to help you," and,
"We pray have you destroyed all the lots according to CFR 21 part
32 subsection 16?"

And answereth the lab, "But peradventure we find that 50 are
good ..."

"You may not keep them. Destroy them as a sin offering on any
day but Saturday between 8 a.m. and midnight on the sixth or eighth day
of any month that is good for you with a fire made of three parts
hyssop, two parts willow, a sprig of myrtle even with the juice of one
lemon--do not laugh."

"Perhaps 25 lots can be kept for even with the plague of the
E. coil it will surely die in the custom of Baal in the dry season and
we will not ship them until the square root of something is calculated
and given to a risk expert who will study the numbers and write a
chapter in the USP and even so the active ingredients are in spec and
the pH is good."

"You may not keep them."

"Peradventure if we irradiate the lots to remove the blemish
off the E. coil, let us say with 25 KiloGreys from the Cobalt-60?"

"You may not keep them."

It came to pass that the laboratory did not hearken unto the words
of the FDA and shipped the lots with dead E. coli and thus went to jail
the Director of Quality, the King, and even the President and all the
Vice-Presidents whom was told this thing is because what is written in
the book of the law as told in CFR 21 Part 211 subsections 84, 113, 188
and 194. This is the law.

H5N1--The Bird Flu

The likeness of any winged fowl that flyeth in the heavens or
dwelleth in the sea or on the lake or pond may bear a pestilence within
its flesh and blood and be a danger of health unto you. And further, as
this pestilence stirs in the air and in the dust it may deal corruptly
with other creatures that crawl or breathe in the air--as in the
beginning was first breathed by man. It is the influenza. It was born on
the farm. Take heed in the plague it may become--there is no vaccine--so
sayeth the nations.

It pleaseth us to note that of all the animals that sojourn near or
upon this pestilence, neither the likeness of the ox, goat, gazelle,
calf or antelope, nor the lesser winged things that swarm upon the
earth, are become sick. It is instead the pig and the chicken. They
dwell together on the farm. So sayeth the nations of the earth, the
journals, the WHO, the New York Times (International edition, February
18, 2012)--so sayeth them all. Of the greater and lesser animals of the
waters, the air and the farms, who among all the creatures of the earth
are most come to perish? It art the chickens.

So therefore take heed that this pestilence are much more greater
than the leprosy which we knew when we were in the Wilderness of Zin, or
the virus that causeth the diarrhea and vomit on the cruising boats in
the Carribean or the bacteria that causeth the Montezuma's
Revenge--it is breathed into the nose like the ferret who dies in the
Tent and the people who are afraid in the street, very much like the
1918--and a child who sings of the coming plague:

"I had a little bird.
Its name was Enza/
I opened the window,
And influenza."

More Wisdom from the Bible

Medicines

Isaiah 38:21 - "For Isaiah had said, Let them take a lump of
figs, and lay it for a plaister upon the boil, and he shall
recover."

2 Kings 2:21 - "And he went forth unto the spring of the
waters, and cast the salt in there, and said, Thus saith the Lord, I
have healed these waters; there shall not be from thence any more death
or barren land."

Cosmetics

Prov. 7:17 - "I have perfumed my bed with myrrh, aloes and
cinnamon."

Prov. 27:9 - "Ointment and perfume rejoice the heart: so doth
the sweetness of a man's friend by hearty counsel."

Exodus 30:35 - "And thou shalt make it a perfume, a confection
after the art of the apothecary, tempered together, pure and holy"

Psalms 45:8 - "All thy garments smell of myrrh, and aloes, and
cassia, out of the ivory palaces, whereby they have made thee
glad."

By Herbert N. Prince and Jason W. Prince

Gibraltar Laboratories

Herbert N. Prince, Ph.D. is scientific director at Fairfield,
NJ-based Gibraltar Laboratories, Inc. Jason W. Prince is a research
assistant and a member of the Regulatory Affairs department at
Gibraltar. For more information about this article, please contact
info@gibraltarlabsinc.com.

COPYRIGHT 2012 Rodman Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.